4 g daily maximum

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INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

the dose in milligrams (mg) and milliliters (mL) is not confused;

the dosing is based on weight for patients under 50 kg;

infusion pumps are properly programmed; and

the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

Acetaminophen is contraindicated in patients with:

– known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.

– severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.

Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.

The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

Pregnancy: Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.

Breast Feeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.

Pediatrics: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc., a Mallinckrodt company, at 1.800.778.7898 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.

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INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

the dose in milligrams (mg) and milliliters (mL) is not confused;

the dosing is based on weight for patients under 50 kg;

infusion pumps are properly programmed; and

the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

Acetaminophen is contraindicated in patients with:

– known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.

– severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.

Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.

The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

Pregnancy: Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.

Breast Feeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.

Pediatrics: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc., a Mallinckrodt company, at 1.800.778.7898 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.

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WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

the dose in milligrams (mg) and milliliters (mL) is not confused;

the dosing is based on weight for patients under 50 kg;

infusion pumps are properly programmed; and

the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

TAP FOR IMPORTANT RISK INFORMATION

INDICATIONS AND USAGE

OFIRMEV® (acetaminophen) injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:

the dose in milligrams (mg) and milliliters (mL) is not confused;

the dosing is based on weight for patients under 50 kg;

infusion pumps are properly programmed; and

the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

Acetaminophen is contraindicated in patients with:

– known hypersensitivity to acetaminophen or to any of the excipients in the intravenous (IV) formulation.

– severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.

Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.

The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

Pregnancy: Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.

Breast Feeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.

Pediatrics: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals, Inc., a Mallinckrodt company, at 1.800.778.7898 or FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.